NCT06281730

Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA.

Conditions

• In Utero Procedure Affecting Fetus or Newborn

Interventions

Type	Name	Description
DEVICE	Karl Storz New Generation Fetoscope - curved 11508AAK	11508AAK Miniature straight forward telescope 0-degree set, curved, diameter 3.3 millimeter, length 30 centimeter, 30,000 pixels, autoclavable, irrigation connector, central working channel 4 french, lateral working channel 3 French., remote eyepiece, fiber optic light transmission incorporated.
DEVICE	Karl Storz New Generation Fetoscope - straight 11506AAK	11506AAK Miniature straight forward telescope 0-degree, straight, diameter 3.3 millimeter, length 30 cm, 30,000 pixels, autoclavable, irrigation connector, central working channel 4 french, lateral working channel 3 french, remote eyepiece, fiber optic light transmission incorporated.

Timeline

• Start date: 2024-03-23
• Primary completion: 2044-02-01
• Completion: 2044-02-01
• First posted: 2024-02-28
• Last updated: 2025-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study